CARECELLA DAILY SUN CREAM- avobenzone, homosalate, octocrylene, octinoxate, octisalate, titanium dioxide cream

Carecella Daily Sun Cream by

Drug Labeling and Warnings

Carecella Daily Sun Cream by is a Otc medication manufactured, distributed, or labeled by General Bio Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone (2.97%) ------------------------------------------------------------------------------- Sunscreen

Homosalate (7.5%) --------------------------------------------------------------------------------- Sunscreen

Octocrylene (7.5%) --------------------------------------------------------------------------------- Sunscreen

Octyl Methoxycinnamate (7.0%) ---------------------------------------------------------------- Sunscreen

Octyl Salicylate (5.0%) ---------------------------------------------------------------------------- Sunscreen

Titanium Dioxide (5.3%) -------------------------------------------------------------------------- Sunscreen

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps to prevent sunburn

WARNINGS

For external use only.

DO NOT USE

• if you are allergic to any of the ingredients
• on damaged or broken skin

WHEN USING

• keep out of eyes. Rinse with water to remove.

STOP USE

• rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

• Apply liberally onto the cleansed entire face and neck 15 minutes prior to sun exposure.
• Reapply as needed or after towel drying, swimming, or sweating.
• Reapply at least every 2 hours: “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.; and wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

• Store in a cool dry place away from direct sunlight.
• “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.”

INACTIVE INGREDIENT

1,2-Hexanediol, Caprylyl/Capryl Oligoglucoside, Acetyl Hexapeptide-8, Adenosine, Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Arginine, Artemisia Vulgaris Top Oil, Bergamot Oil, Butylene Glycol, C13-15 Alkane, Caprylyl/Capryl Oligoglucoside, Caprylyl Glycol, Centella Asiatica Extract, Chamaemelum Nobile (Anthemis Nobilis) Flower Oil, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dipropylene Glycol, Edetate Sodium, Ethyl Ferulate, Glycerin, Glyceryl Monostearate, Hexapeptide-9, Hydroxyacetophenone, Lavender Oil, Niacinamide, Octinoxate, Octisalate, Orange (Citrus Aurantium Dulcis) Peel Oil Palmarosa Oil, Polyisobutylene, Polyglyceryl-10 Laurate, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-5 Trioleate, Polyhydroxystearic Acid, Polyisobutylene, Prezatide, Prezatide Copper, Propanediol, Rosa Rugosa Flower Bud Oil, Rosemary (Rosmarinus Officinalis) Leaf Extract, Silicon Dioxide, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer, Sorbitan Isostearate, Sorbitan Monooleate, Succinoglycan, Sunflower (Helianthus Annuus) Seed Oil, Tocopherol, Triethoxycaprylylsilane, Tripeptide-3, Uridine Monophosphate Disodium, Water, Yellow Wax

Carecella Daily Sun Cream

INGREDIENTS AND APPEARANCE

CARECELLA DAILY SUN CREAM 
avobenzone, homosalate, octocrylene, octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-1004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.97 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
C13-15 ALKANE (UNII: 114P5I43UJ)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
HEXAPEPTIDE-9 (UNII: L25414IE41)
LAVENDER OIL (UNII: ZBP1YXW0H8)
NIACINAMIDE (UNII: 25X51I8RD4)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
EDETATE SODIUM (UNII: MP1J8420LU)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYL FERULATE (UNII: 5B8915UELW)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PROPANEDIOL (UNII: 5965N8W85T)
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
POLYGLYCERYL-5 TRIOLEATE (UNII: SZ1T9D7ZKX)
ADENOSINE (UNII: K72T3FS567)
ROSEMARY (UNII: IJ67X351P9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARTEMISIA VULGARIS TOP OIL (UNII: 72Q967Y48V)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
PREZATIDE (UNII: 39TG2H631E)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)
WATER (UNII: 059QF0KO0R)
PALMAROSA OIL (UNII: 0J3G3O53ST)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-1004-2	1 in 1 BOX	10/07/2020
1	NDC: 69422-1004-1	50 g 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	10/07/2020

Labeler - General Bio Co., Ltd. (695273863)

Registrant - General Bio Co., Ltd. (695273863)

Establishment
Name	Address	ID/FEI	Business Operations
General Bio Co., Ltd.		695273863	manufacture(69422-1004)