Sunscreen Lotion Spf 30

Sunscreen Lotion Spf 30
SPL v4
SPL
SPL Set ID fff721da-5159-4ff2-b683-50d2889b2c61
Route
TOPICAL
Published
Effective Date 2012-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.0 mL) Homosalate (6.5 mL) Octinoxate (7.0 mL) Octisalate (5.0 mL) Oxybenzone (3.0 mL)
Inactive Ingredients
Morinda Citrifolia Fruit Glyceryl Monostearate Alkyl (c12-15) Benzoate Glycerin Cetostearyl Alcohol Dimethicone Morinda Citrifolia Seed Oil Vitis Vinifera Seed Shea Butter Coconut Oil Gardenia Taitensis Flower Ascorbyl Palmitate Vitamin A Palmitate Potassium Sorbate Edetate Disodium Sodium Hydroxide Phenoxyethanol Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-06-28

Description

Active Ingredients           purpose Avobenzone 2%            Sunscreen Homosalate 6.5%         Sunscreen Octinoxate 7%              Sunscreen   Octisalate 5%                Sunscreen Oxybenzone 3%            Sunscreen


Medication Information

Warnings and Precautions
Warnings



For External Use only



When using this product

Keep out of eyes. If contact occurs, rinse thoroughly with water

.

If swallowed, get medical help or contact a poison control center right away.





Indications and Usage

Stop use and ask a doctor if

-rash or irritation develops and lasts

Dosage and Administration


Directions:

Apply liberally before sun exposure

Reapply as needed or after towel drying, swimming, or sweating

Ask a doctor before using on children under 6 months of age

Description

Active Ingredients           purpose Avobenzone 2%            Sunscreen Homosalate 6.5%         Sunscreen Octinoxate 7%              Sunscreen   Octisalate 5%                Sunscreen Oxybenzone 3%            Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6


Inactive Ingredients: Water (Aqua), Morinda citrifolia (Noni) fruit juice, Glyceryl Stearate SE, C12-15 Alkyl Benzoate, Glycerin, Cetearyl Alcohol, Dimethicone, Ceteareth-20, Morinda citrifolia (Noni) Seed Oil, Prunus Amygdalus dulcis (sweet almond) Oil, Elaeis guinesssis (palm) Oil, Butyrospermum parkii (Shea Butter), Vitis vinifera (grape) seed extract, cocos nucifera oil, Gardenia tahitensis (Tiare) flower, Ascorbyl palmitate, retinyl palmitate Carbomer,potassium sorbate, disodium EDTA, Sodium Hydroxide, phenoxy ethanol, caprylyl glycol, tocopheryl acetate, Fragrance (parfum).











Section 51945-4

Tahitian Noni

Sunscreen Lotion

SPF 30

200 ml 6.76 fl.oz.









Section 55105-1

Use   helps prevent sunburn

Section 55106-9

Active Ingredients           purpose

Avobenzone 2%            Sunscreen

Homosalate 6.5%         Sunscreen

Octinoxate 7%              Sunscreen  

Octisalate 5%                Sunscreen

Oxybenzone 3%            Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if

-rash or irritation develops and lasts

Dosage and Administration (34068-7)


Directions:

Apply liberally before sun exposure

Reapply as needed or after towel drying, swimming, or sweating

Ask a doctor before using on children under 6 months of age

Warnings and Precautions (34071-1)
Warnings



For External Use only



When using this product

Keep out of eyes. If contact occurs, rinse thoroughly with water

.

If swallowed, get medical help or contact a poison control center right away.





Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)


Inactive Ingredients: Water (Aqua), Morinda citrifolia (Noni) fruit juice, Glyceryl Stearate SE, C12-15 Alkyl Benzoate, Glycerin, Cetearyl Alcohol, Dimethicone, Ceteareth-20, Morinda citrifolia (Noni) Seed Oil, Prunus Amygdalus dulcis (sweet almond) Oil, Elaeis guinesssis (palm) Oil, Butyrospermum parkii (Shea Butter), Vitis vinifera (grape) seed extract, cocos nucifera oil, Gardenia tahitensis (Tiare) flower, Ascorbyl palmitate, retinyl palmitate Carbomer,potassium sorbate, disodium EDTA, Sodium Hydroxide, phenoxy ethanol, caprylyl glycol, tocopheryl acetate, Fragrance (parfum).











Section 51945-4 (51945-4)

Tahitian Noni

Sunscreen Lotion

SPF 30

200 ml 6.76 fl.oz.









Section 55105-1 (55105-1)

Use   helps prevent sunburn

Section 55106-9 (55106-9)

Active Ingredients           purpose

Avobenzone 2%            Sunscreen

Homosalate 6.5%         Sunscreen

Octinoxate 7%              Sunscreen  

Octisalate 5%                Sunscreen

Oxybenzone 3%            Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)