ACTIVE SKIN REPAIR HYDRATING DAILY SUNSCREEN- zinc oxide lotion

Active Skin Repair hydrating daily sunscreen by

Drug Labeling and Warnings

Active Skin Repair hydrating daily sunscreen by is a Otc medication manufactured, distributed, or labeled by Innovacyn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc oxide, 19.6 %

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 useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove
Stop use and ask a doctor ifrash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating:
• immediately after towel drying
• at least every 2 hours
• 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, C13-15 alkane, butyloctyl salicylate, ethylhexyl olivate, glycerin, zea mays (corn) starch, argania spinosa kernel oil, propanediol, tocopheryl acetate, polyhydroxystearic acid, inulin lauryl carbamate, pentylene glycol, 1,2-hexanediol, betaine, biosaccharide gum-4, bisabolol, cellulose, ethylhexylglycerin, eugenia caryophyllus (clove) bud extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, lauroyl lysine, niacinamide, panthenol, phenoxyethanol, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, silica, sodium acrylates crosspolymer-2, sodium hyaluronate, solidago virgaurea (goldenrod) extract, sorbitan isostearate, squalane, tocopherol, trisodium ethylenediamine disuccinate

Product label

INGREDIENTS AND APPEARANCE

ACTIVE SKIN REPAIR HYDRATING DAILY SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70489-1615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C13-15 ALKANE (UNII: 114P5I43UJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
GLYCERIN (UNII: PDC6A3C0OX)
ZEA MAYS (CORN) STARCH (UNII: O8232NY3SJ)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
BISABOLOL (UNII: 24WE03BX2T)
LAUROYL LYSINE (UNII: 113171Q70B)
CLOVE (UNII: K48IKT5321)
SQUALANE (UNII: GW89575KF9)
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)
TOCOPHEROL (UNII: R0ZB2556P8)
BETAINE (UNII: 3SCV180C9W)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70489-1615-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	06/26/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/26/2025

Labeler - Innovacyn, Inc. (025217003)