Private Label Super Light Oil-free Spf45

Private Label Super Light Oil-free Spf45
SPL v3
SPL
SPL Set ID 6a08448a-46bc-4330-ae2d-f716bb4edfa7
Route
TOPICAL
Published
Effective Date 2023-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (27.5 g) Octinoxate (75.0 g) Zinc Cation (80.0 g)
Inactive Ingredients
Water Triethoxycaprylylsilane Citric Acid Monohydrate Butylene Glycol Phenoxyethanol Iodopropynyl Butylcarbamate Hyaluronate Sodium Cyclomethicone 5 Octyldodecyl Neopentanoate Ascorbyl Palmitate Oleth-3 Phosphate Vitamin A Palmitate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polyisobutylene (1300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-03-22

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

Use

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.

Use 

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.

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 at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10a.m. to 2p.m. Wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

Active Ingredients

Octinoxate 7.50%

Octisalate 2.75%

Zinc Oxide 8.00%

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acrylouldimethyl Taurate Copolymer, Idodopropynyl Butylcarbamate, Octyldodecyl neopentanoate, Oleth-3 Phosphate, PEG-7 Triethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Purified Water, Retinyl Palmitate, Triethocycaprylysilane

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Use

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.

Use 

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.

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 at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10a.m. to 2p.m. Wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

Active Ingredients

Octinoxate 7.50%

Octisalate 2.75%

Zinc Oxide 8.00%

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acrylouldimethyl Taurate Copolymer, Idodopropynyl Butylcarbamate, Octyldodecyl neopentanoate, Oleth-3 Phosphate, PEG-7 Triethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Purified Water, Retinyl Palmitate, Triethocycaprylysilane

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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