146dc4c9-83a1-4801-b92f-fe472dfa23df

SPL v2
SPL
SPL Set ID 146dc4c9-83a1-4801-b92f-fe472dfa23df
Route
topical
Published
Effective Date 2016-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (20 mg) octinoxate (75 mg) octisalate (50 mg) octocrylene (15 mg) oxybenzone (60 mg)
Inactive Ingredients
water alkyl (c12-15) benzoate butylene glycol octyldodecyl neopentanoate cyclomethicone 5 medium-chain triglycerides glycerin sorbitan monooleate ubidecarenone physalis angulata teprenone hyaluronate sodium green tea leaf actinidia chinensis root artemisia vulgaris root centella asiatica echinacea purpurea palmitoyl pentapeptide-4 leontopodium alpinum flower arabidopsis thaliana aloe vera leaf polygonum aviculare top xanthan gum egg phospholipids carbomer copolymer type b (allyl pentaerythritol crosslinked) carbomer copolymer type a (allyl pentaerythritol crosslinked) polysorbate 20 trolamine phenoxyethanol caprylyl glycol ethylhexylglycerin hexylene glycol polyethylene glycol 400 tocopherol ascorbyl palmitate ascorbic acid citric acid monohydrate edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-07-26
Description

Active Ingredients: ZINC OXIDE 18.6%   

Medication Information

Warnings and Precautions

Warnings: For external use only.

Active Ingredient

Active Ingredients:

ZINC OXIDE 18.6%   

Indications and Usage

Uses:

  • High protection against sunburn.
  • Higher SPF gives more sunburn protection.

Dosage and Administration

Directions:

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply as needed or after towel drying, swimming or perspiring.
  • children under 6 months of age: ask a doctor.

Inactive Ingredients

Water (Aqua), Cycclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyaqcrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice Powder, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

Description

Active Ingredients: ZINC OXIDE 18.6%   

Section 44425-7

Protect the product in in this container from excessive heat and direct sun.

Section 50565-1

Keep out of reach of children.

Section 50567-7

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

Section 50569-3

Stop use ans ask a doctor if rash occurs.

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Structured Label Content

Warnings and Precautions (34071-1)

Warnings: For external use only.

Active Ingredient (55106-9)

Active Ingredients:

ZINC OXIDE 18.6%   

Indications and Usage (34067-9)

Uses:

  • High protection against sunburn.
  • Higher SPF gives more sunburn protection.

Dosage and Administration (34068-7)

Directions:

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply as needed or after towel drying, swimming or perspiring.
  • children under 6 months of age: ask a doctor.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Cycclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyaqcrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice Powder, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

Section 44425-7 (44425-7)

Protect the product in in this container from excessive heat and direct sun.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Stop use ans ask a doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.680789 · Updated: 2026-03-14T22:54:23.335310