HYGIENELAB FACE AND BODY MINERAL SUNSCREEN SPF 50- zinc oxide cream

HygieneLab Face and Body Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

HygieneLab Face and Body Mineral Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by HYGIENELAB, INC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 17.50%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• higher SPF gives more sunburn protection
• retains SPF after 80 minutes of swimming or sweating
• 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.
• Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

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:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• do not spray directly on face. Spray into hands and apply to face.
• Use in well ventilated areas
• 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 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

Adansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) FruitExtract, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid,Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water(Aqua), Xanthan Gum

Questions?

(213) 577-2600

Package Labeling:

INGREDIENTS AND APPEARANCE

HYGIENELAB FACE AND BODY MINERAL SUNSCREEN SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87116-879
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	175 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
SHEA BUTTER (UNII: K49155WL9Y)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
CUCUMBER (UNII: YY7C30VXJT)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
AVOCADO OIL (UNII: 6VNO72PFC1)
PROPANEDIOL (UNII: 5965N8W85T)
POMEGRANATE (UNII: 56687D1Z4D)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
BLUEBERRY (UNII: 253RUG1X1A)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87116-879-00	1 in 1 BOX	08/25/2025
1		177 mL in 1 TUBE; 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	08/25/2025

Labeler - HYGIENELAB, INC (144832200)

Registrant - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(87116-879)