Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID bab8447b-58b8-4160-a91e-05f9fd09ed1d
Route
TOPICAL
Published
Effective Date 2018-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg) Octinoxate (75 mg) Octisalate (30 mg) Oxybenzone (30 ug)
Inactive Ingredients
Ceresin Squalane Ethylhexyl Palmitate Petrolatum Myristyl Myristate Myristyl Lactate Cetyl Alcohol Myristyl Laurate Myristyl Alcohol Butylated Hydroxytoluene Menthol, Unspecified Form .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-15
Description

Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%

Purpose

Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen Oxybenzone - Sunscreen

Medication Information

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Description

Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increased your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
Do Not Use

on damaged or broken skin

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Inactive Ingredients

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Principal Display Panel
When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If
  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increased your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Inactive Ingredients (Inactive ingredients)

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Principal Display Panel
When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.691723 · Updated: 2026-03-14T23:05:57.575147