Drug Facts

Active ingredient

Zinc oxide 15.5%

Purpose

Sunscreen

Uses

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

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 occurs

Keep out of reach of children.

If 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
Children under 6 months of age: Ask a doctor
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 value 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-sleeved shirts, pants, hats and sunglasses

Other information

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

Inactive ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Glycerin, Ethylhexyl Palmitate, Propanediol, Shea Butter (Butyrospermum Parkii), Safflower (Carthamus Tinctorius) Oleosomes, Glyceryl Stearate Se, Polyhydroxystearic Acid, Sorbitan Isostearate, Cetyl Alcohol, Pentaerythrityl Tetraisostearate, Phenyl Trimethicone, Silica, Inulin Lauryl Carbamate, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Hydroxyacetophenone, Polysilicone-11, Xanthan Gum, Gluconolactone, Trisodium Ethylenediamine Disuccinate, Sodium Citrate, Sodium Benzoate, Tocopherol, Citric Acid.

Package Labeling:

Label Inner Package

DAILY SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:31720-231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	155 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPANEDIOL (UNII: 5965N8W85T)
SHEA BUTTER (UNII: K49155WL9Y)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CETYL ALCOHOL (UNII: 936JST6JCN)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
XANTHAN GUM (UNII: TTV12P4NEE)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:31720-231-10	1 in 1 BOX	11/15/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/15/2023

Labeler - S+ (572406531)

DAILY SUNSCREEN CREAM BROAD SPECTRUM SPF 30