SUNSCREEN KARINA SKIN CARE SPF 15- octinoxate, emulsion

Sunscreen Karina Skin Care SPF 15 by

Drug Labeling and Warnings

Sunscreen Karina Skin Care SPF 15 by is a Otc medication manufactured, distributed, or labeled by CA-Botana International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%.............................................Sunscreen

Purpose

Sunscreen

Ask Doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children

Inactive Ingredients

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Alanine, Allantoin, Aloe Barbadensis, Alpha Acetyl Tetrapeptide -5, Arginine, Camellia Sinensis (White tea) extract, Cetearyl Alcohol, Ceteary Isononanoate, Ceteareh-20, Cetyl Alcohol, Chamomillla recutita (Chamomile) extract, Coco-Caprylate/Caprate, Emulsifying Wax, Euterpe oleracea(Acai) Fruit extract, Ethtlhexylglycerin, Ethylhexyl Palmitate, Ginkgo Biloba leaf extract, Glycerin, Glycine, Juniperus Oxycedrus (Juniper berry ) extract, Malpighia glabra(Acerola) Fruit extract, Olea Europaea (Olive) Leaf extract, OXI CA (Rosmarinus officinalis leaf extract CO2 & Ascorbyl Palmitate & Caprylic/Capric/Tryglyceride & Ascorbic Acid, & Tocopherol & Citric Acid), Panthenol, Pentylene Glycol, Phenoxyethanol, Phosphatidylcholine, Potassium Sorbate, Prunus amygdalus dulcis (Sweet almond) oil, Proline, Propanediol, Simmondsia chinensis (Jojoba) Seed oil, Tetrasodium EDTA, Triethanolamine, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Safety information

Protect this product from excessive heat and direct sun

Dosage & Administration

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct 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. If product is swallowed get medical help or contact a poison Control Center right away.

Indications & Usage

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

Karina SPF 15

INGREDIENTS AND APPEARANCE

SUNSCREEN KARINA SKIN CARE SPF 15 
octinoxate, emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 141.7 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WATER (UNII: 059QF0KO0R)
CETEARETH-22 (UNII: 28VZG1E234)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALMOND OIL (UNII: 66YXD4DKO9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALANINE (UNII: OF5P57N2ZX)
JUNIPER BERRY (UNII: O84B5194RL)
ACETYL TETRAPEPTIDE-5 (UNII: Y1DFQ308G8)
ARGININE (UNII: 94ZLA3W45F)
SOYBEAN PHOSPHATIDYLCHOLINE (UNII: 1T6N4D9YV6)
EDETIC ACID (UNII: 9G34HU7RV0)
ACEROLA (UNII: XDD2WEC9L5)
ROSEMARY (UNII: IJ67X351P9)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROLINE (UNII: 9DLQ4CIU6V)
WHITE TEA (UNII: O0M3396E09)
CHAMOMILE (UNII: FGL3685T2X)
ACAI (UNII: 46AM2VJ0AW)
GLYCINE (UNII: TE7660XO1C)
PANTHENOL (UNII: WV9CM0O67Z)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
GINKGO BILOBA ROOT (UNII: 1XUK686051)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white (white yellowish)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-045-16	141.7 g in 1 TUBE; Type 0: Not a Combination Product	01/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/24/2022

Labeler - CA-Botana International (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-045)