Private Label Spf45 Water Resistant Paraben Free Sunscreen

Private Label Spf45 Water Resistant Paraben Free Sunscreen
SPL v3
SPL
SPL Set ID f997f4fc-7da5-433c-9a53-2030b489b4f6
Route
TOPICAL
Published
Effective Date 2023-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (80 g) Octinoxate (75 g) Octisalate (30 g)
Inactive Ingredients
Vitamin A Palmitate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Ethylhexyl Isononanoate Triethoxycaprylylsilane Butylene Glycol Phenoxyethanol Iodopropynyl Butylcarbamate Water Sodium Chloride Cyclomethicone 5 Ascorbyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-08-31

Description

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. Stop use and ask physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Medication Information

Description

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. Stop use and ask physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Labeling

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. Stop use and ask physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Active Ingredients

Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Cylcopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isonnonanoate, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethyoxycaprylylsilane

Keep Out of Reach of Children

Keep Out of Reach of Children


Structured Label Content

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Labeling

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. Stop use and ask physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Active Ingredients

Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Cylcopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isonnonanoate, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethyoxycaprylylsilane

Keep Out of Reach of Children

Keep Out of Reach of Children


Advanced Ingredient Data


Raw Label Data

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