SKIN TINTED SUNSCREEN MAKEUP PRIMER SPF 30, BEIGE- avobenzone, homosalate, octisalate, octocrylene cream

Skin Tinted Sunscreen Makeup Primer SPF 30, Beige by

Drug Labeling and Warnings

Skin Tinted Sunscreen Makeup Primer SPF 30, Beige by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuanyue Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 7.5%

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 agingcaused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If swallowed, call a Poison Control Center or get medical help right away

Directions

• Apply liberally/generously (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
• Sun Protection Measures: Spending time in the sun increase 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.-2p.m.
• wear long-sleeved shirts, pants,hats,and sunglasses.
• children under 6 months: Ask a doctor

Inactive ingredients

Water, Diisopropyl Sebacate, Glycerin, Isodecyl NeopentanOate,Butyloctyl Salicylate,Bismuth Oxychloride, Isododecane,c12-13 Alkyl Lactate, Glyceryl Stearate,Brassica Campestris/Aleurites Fordi Oil Copolymer, Saccharomyces Ferment,Stearyl Glycyrrhetinate,Helianthus Annuus (Sunflower) Seed Oil,Butyrospermum Parkii (Shea) Butter,Ethylhexyl Hydroxystearate,Panthenol,Propanediol,Dipropylene Glycol,Peg-100 Stearate, Cetearyl Glucoside, Camellia Sinensis Seed Oil, Squalane,Sodium Stearoyl Glutamate, Cetaryl Alcohol,Dictamnus Dasycarpus Root Bark Extract,Sorbitan Olivate,Tocopherol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Arginine,Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer,Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Alteromonas Ferment Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Butylene Glycol,camellia Sinensis Leaf Extract,citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Limon (Lemon) Fruit Extract,Juniperus Chinensis Xylem Extract, Polyquaternium-61, citrus Aurantium Bergamia (Bergamot) Fruit Oil,Juniperus Virginiana Oil,Citrus Sinensis Extract,Cananga Odorata Flower Oil,Styrax Benzoin Extract,Michelia Alba Leaf Oil, Allantoin, Disodium Edta,Xanthan Gum, Triethoxycaprylylsilane, Hydroxyacetophenone, 1,2-Hexanediol,Caprylyl Glycol,Iron Oxides.

Other information

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

Questions?

Call AP Specialties

Package Labeling:

INGREDIENTS AND APPEARANCE

SKIN TINTED SUNSCREEN MAKEUP PRIMER SPF 30, BEIGE 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84102-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
ISODODECANE (UNII: A8289P68Y2)
C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
PANTHENOL (UNII: WV9CM0O67Z)
PROPANEDIOL (UNII: 5965N8W85T)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
SQUALANE (UNII: GW89575KF9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)
ARGININE (UNII: 94ZLA3W45F)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MANDARIN OIL (UNII: NJO720F72R)
LEMON (UNII: 24RS0A988O)
BERGAMOT OIL (UNII: 39W1PKE3JI)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
YLANG-YLANG OIL (UNII: 8YOY78GNNX)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84102-001-00	1 in 1 CARTON	09/01/2024
1		1 in 1 BOX
1		40 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	09/01/2024

Labeler - Shanghai Chuanyue Biotechnology Co., Ltd. (841882128)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuanyue Biotechnology Co., Ltd.		841882128	manufacture(84102-001)