GIRLYISH SKINCARE MINERAL SUNSCREEN SPF 30- zinc oxide lotion

Girlyish Skincare Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Girlyish Skincare Mineral Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Rise Skincare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 18.00%

Purpose

Mineral Sunscreen

Uses:

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• 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.

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 a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

Directions:

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection meaasures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information:

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Adansonia Digitata Oil, Arginine Cocoate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C13-16 Isoalkane, Caramel, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cirtullus Lanatus (Watermelon) Fruit Extract, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Glycerin, Hellianthus Annuuss (Sunflower) Seed Oil, Heptyl Undecylenate, Hippophae Rhamnoides Fruit Oil, Iron Oxides, Jojoba Esters, Methyl Dihydroabietate, Mica, Phenoxyethanol, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Sesquioleate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide (CI 77891), Tocopherol, Water (Aqua), Xanthan Gum

Questions?

(801)-214-8368

Package Labelling:

INGREDIENTS AND APPEARANCE

GIRLYISH SKINCARE MINERAL SUNSCREEN SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84980-548
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	180 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADANSONIA DIGITATA OIL (UNII: 77MKL7AR5I)
ARGININE COCOATE (UNII: 951Q8XZ62H)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
CARAMEL (UNII: T9D99G2B1R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
IRON OXIDES (UNII: 1K09F3G675)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 BEESWAX (UNII: Z98M8HW9A6)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
COCOA BUTTER (UNII: 512OYT1CRR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84980-548-00	1 in 1 BOX	10/29/2024
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/29/2024

Labeler - Rise Skincare LLC (110650077)