GENTLE HYDRATING SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

Gentle Hydrating Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Gentle Hydrating Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide 18.9%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Direction), this product decreases the risk of skin cancer and  early skin aging caused by the sun.

WARNINGS AND PRECAUTIONS

Warning: For external use only.

DO NOT USE

Do not use: on damaged or broken skin.

WHEN USING

When using this product: Keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor: If rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions:

• Apply generously 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor. 
• Reapply at least every 2 hours.
• Sun protection measures: Spending time in the sun increase 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:
• Limit time in the sun, especially from 10am - 2pm.
• Wear long sleeved shirts, pants, hats and sunglasses.

Other Information: Protect the product from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Cetearyl Glucoside, Caprylyl/Capryl Glucoside, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Sodium Phytate, Lecithin, Tocopherol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Ethylhexylglycerin,  Sodium Benzoate, Potassium Sorbate.

QUESTIONS

Questions or Comments?

Call toll free 707-230-2284; www.eczemahoneyco.com

PRINCIPAL DISPLAY PANEL

Manufactured by Allure Labs

For Eczema Honey CO IN

Partnership:

Hayward, CA, 94545

INGREDIENTS AND APPEARANCE

GENTLE HYDRATING SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	189 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT ALKANES (UNII: 1E5KJY107T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO GLUCOSIDE (UNII: ICS790225B)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
APPLE (UNII: B423VGH5S9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SHEANUT (UNII: 84H6HBP32L)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4189-1	57 g in 1 TUBE; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/24/2020

Labeler - Allure Labs Inc (926831603)