BLDG ACTIVE SKIN REPAIR FACE AND BODY PERFORMANCE SUNSCREEN- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient                         Purpose

Zinc oxide, 22%.......................... Sunscreen

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• 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, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Polyglyceryl-10 Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/ Sebacate, Aloe Barbadensis Leaf Juice, Hydrogenated Methyl Abietate, Capryloyl Glycerin/Sebacic Acid Copolymer, Polyglyceryl-2 Dipolyhydroxystearate, Caprylhydroxamic acid, Glyceryl Caprylate,
Glycerin, Lecithin (Soy), Sorbitan Sesquioleate, Tapioca Starch, Pongamia Pinnata Seed Extract, Tocopherol, Bisabolol, Sodium Phytate, Niacinamide, Sodium Hyaluronate (Hyaluronic Acid)

Product label

INGREDIENTS AND APPEARANCE

BLDG ACTIVE SKIN REPAIR FACE AND BODY PERFORMANCE SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70489-1424
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STARCH, TAPIOCA (UNII: 24SC3U704I)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
PHYTATE SODIUM (UNII: 88496G1ERL)
NIACINAMIDE (UNII: 25X51I8RD4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70489-1424-1	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/24/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/24/2026

Labeler - Innovacyn, Inc. (025217003)