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sheer

RYSHI 978.000/978AA Sheer Touch Sunscreen SPF 70

Approved
Approval ID

299a6690-9746-4410-a625-7636f0b4a754

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Rite Aid

DUNS: 014578892

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 Code11822-1978
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (24)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)Inactive
Code: 5Z4DPO246A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAPRYLYL TRISILOXANEInactive
Code: Q95M2P1KJL
Classification: IACT
CETYL DIMETHICONE 150Inactive
Code: 5L694Y0T22
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)Inactive
Code: JZ1374NL9E
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive
Code: 5041RX63GN
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 150 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

principal display panel

SHEER TOUCH SUNSCREEN

SUNSCREEN LOTION

70

BROAD SPECTRUM SPF 70

WATER RESISTANT

RYSHI TM

WATER RESISTANT

UP TO 80 MINUTES

QUICKLY ABSORBS

COMPARE TO NEUTROGENA ®ULTRA SHEER SUNSCREEN*

3 FL OZ (88 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

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: 8/12/2025

ADVERSE REACTION

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE:

If you're not satisfied, we'll happily refund your money.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/12/2025

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/12/2025

When using this product

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/12/2025

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/12/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

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 risk, 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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/12/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

inactive ingredients

water, styrene/acrylates copolymer, silica, diethylhexyl 2,6-naphthalate, beeswax, glyceryl stearate, PEG-100 stearate, glycerin, caprylyl methicone, cetyl dimethicone, sodium polyacrylate, acrylates/C12-22 alkyl methacrylate copolymer, dimethicone, xanthan gum, pentylene glycol, trimethylsiloxysilicate, disodium EDTA, fragrance, BHT, benzyl alcohol, chlorphenesin

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/12/2025

Disclaimers

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 70.

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sheer - FDA Drug Approval Details