83154-004_elroel Pang Pang Sun Cushion Plus

83154-004_elroel Pang Pang Sun Cushion Plus
SPL v6
SPL
SPL Set ID 5ffaad65-f0b2-416a-b0a3-b92e880641e4
Route
TOPICAL
Published
Effective Date 2025-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.52 g) Zinc Cation (9.7 g) Octinoxate (7 g) Octisalate (3 g)
Inactive Ingredients
Propylene Carbonate Aluminum Oxide Glycerin Ethylhexylglycerin Shea Butter Adenosine Xylitylglucoside Anhydroxylitol Edetate Disodium Anhydrous Methyl Diisopropyl Propionamide Laminaria Japonica Ulmus Davidiana Root Viola Mandshurica Flower Dioscorea Japonica Tuber Xylitol Ferric Oxide Yellow 1,2-hexanediol Anhydrous Dextrose Menthyl Lactate, (-)- Yellow Wax Ethyl Menthane Carboxamide Glyceryl Monostearate Medium-chain Triglycerides Calcium Pantothenate Centella Asiatica Triterpenoids Sucrose Stearate Stearamidopropyl Dimethylamine Lactate Phenylethyl Alcohol Peg-100 Stearate Sodium Ascorbyl Phosphate Cetostearyl Alcohol Glycyrrhizinate Dipotassium Pyridoxine Hydrochloride Madecassoside Madecassic Acid Asiaticoside Asiatic Acid Aloe Vera Leaf Cyclomethicone 5 Amiloxate Caprylyl Trisiloxane Butylene Glycol Diethylamino Hydroxybenzoyl Hexyl Benzoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Cyclomethicone 6 Niacinamide Diphenylsiloxy Phenyl Trimethicone Alcohol Propylene Glycol Dicaprylate Sodium Chloride Silicon Dioxide Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Hydroxyacetophenone Synthetic Beeswax Disteardimonium Hectorite Triethoxycaprylylsilane Dipropylene Glycol Water Caprylyl Glycol Squalane .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-03

Description

ZINC OXIDE 9.70% OCTINOXATE 7.00% OCTISALATE 3.00% TITANIUM DIOXIDE 1.52%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

Indications and Usage

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused

by the sun.

Dosage and Administration

- Apply liberally 15 minutes before sun exposure.

- 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 of 15 or higher and other sun protection measures including: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

- Children under 6 months of age: Ask a doctor.

Description

ZINC OXIDE 9.70% OCTINOXATE 7.00% OCTISALATE 3.00% TITANIUM DIOXIDE 1.52%

Section 50565-1

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

Section 51727-6

Aloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

ZINC OXIDE 9.70%

OCTINOXATE 7.00%

OCTISALATE 3.00%

TITANIUM DIOXIDE 1.52%

Section 60561-8

Protect the product in this container from excessive heat and direct sunlight


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused

by the sun.

Dosage and Administration (34068-7)

- Apply liberally 15 minutes before sun exposure.

- 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 of 15 or higher and other sun protection measures including: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

- Children under 6 months of age: Ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

ZINC OXIDE 9.70%

OCTINOXATE 7.00%

OCTISALATE 3.00%

TITANIUM DIOXIDE 1.52%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sunlight


Advanced Ingredient Data


Raw Label Data

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