MedPath

Sunscreen for Babies SPF 50

Care One D47AA/D47.001 Sunscreen Lotion for Babies SPF 50

Approved
Approval ID

64766ed9-bd47-498d-bf59-fb30a7bf7e89

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Retail Business Services, LLC

DUNS: 967989935

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72476-947
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (29)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)Inactive
Code: 5Z4DPO246A
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ARACHIDYL ALCOHOLInactive
Code: 1QR1QRA9BU
Classification: IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 809Y72KV36
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
DOCOSANOLInactive
Code: 9G1OE216XY
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
ARACHIDYL GLUCOSIDEInactive
Code: 6JVW35JOOJ
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
SODIUM ASCORBYL PHOSPHATEInactive
Code: 836SJG51DR
Classification: IACT
.ALPHA.-HEXYLCINNAMALDEHYDEInactive
Code: 7X6O37OK2I
Classification: IACT
ISOMETHYL-.ALPHA.-IONONEInactive
Code: 9XP4LC555B
Classification: IACT
GERANIOLInactive
Code: L837108USY
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 120 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Principal Panel Display

CAREone ®

Compare to Coppertone ® Sunscreen Lotion Water Babies ® SPF 50*

Baby Sunscreen Lotion

SPF 50

UVA/UVB SUNSCREEN

Broad Spectrum SPF 50

  • Water resistant (80 min)

8 FL OZ (236 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (SeeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/20/2025

Adverse Reaction

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Empty Before Recycling

PLASTIC BOTTLE

how2recycle.info

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/20/2025

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/20/2025

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/20/2025

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/20/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Sunscreen

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

Directions

  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours *Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this rist, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy from 10 a.m. -2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/20/2025

Other information

  • protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

inactive ingredients

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/20/2025

Disclaimers

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ® Sunscreen Lotion Water Babies Broad Spectrum SPF 50.

May stain or damage some fabrics or surfaces

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