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Daily Body Moisturizer Sunscreen Broad Spectrum SPF 50

Daily Body Moisturizer Sunscreen Broad Spectrum SPF 50+

Approved
Approval ID

3e115ef1-f039-4c72-e063-6394a90a7e64

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 5, 2025

Manufacturers
FDA

Baxter Laboratories Pty. Ltd.

DUNS: 740537709

Products 1

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

Avobenzone, Homosalate, Octisalate, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70157-029
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 5, 2025
FDA Product Classification

INGREDIENTS (20)

BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
OCTOCRYLENEActive
Quantity: 8 g in 100 mL
Code: 5A68WGF6WM
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
AVOBENZONEActive
Quantity: 3 g in 100 mL
Code: G63QQF2NOX
Classification: ACTIB
CETEARETH-20Inactive
Code: YRC528SWUY
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
OCTISALATEActive
Quantity: 5 g in 100 mL
Code: 4X49Y0596W
Classification: ACTIB
SODIUM STEAROYL GLUTAMATEInactive
Code: 65A9F4P024
Classification: IACT
HOMOSALATEActive
Quantity: 10 g in 100 mL
Code: V06SV4M95S
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/5/2025

Daily Body Moisturizer

SPF 50+

Non-Greasy

Sunscreen Broad Spectrum SPF50+

Water Resistant (80 Minutes)

5.0 fl. oz. (148 mL)

Daily Body SPF 50

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/5/2025

Stop use and ask a doctor if rash occurs

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/5/2025

Active Ingredient Purpose

Avobenzone Sunscreen

Homosalate

Octisalate

Octocrylene

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/5/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/5/2025

Keep out of reach of children. If Product is swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/5/2025

Warnings

For external Use Only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/5/2025

Directions

  • Apply liberally 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 risk, regularly use a sunscreen with a Broad Spectrum SPF value 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/5/2025

Inactive ingredientsWater, Beeswax, Cyclomethicone, Isopropyl Palmitate, Cetearyl Alcohol, Ceteareth-20, Carbomer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Hydroxyacetophenone, Phenoxyethanol, Triethanolamine, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric Acid

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/8/2025

Other information

  • protect this product from excessive heat and direct sun

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Daily Body Moisturizer Sunscreen Broad Spectrum SPF 50 - FDA Drug Approval Details