DailyMed - ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

Contains inactivated NDC Code(s)
NDC Code(s): 68807-302-01, 68807-302-02, 68807-302-03, 68807-302-04, view more
68807-302-05, 68807-302-06, 68807-302-07, 68807-302-08, 68807-302-09, 68807-302-10
Packager: Temmentec AG

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 3, 2017

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ACTIVE INGREDIENT
Active ingredients purpose - Avobenzone 3.0% Sunscreen - Octinoxate 7.5% Sunscreen - Octisalate 5.0% Sunscreen - Octocrylene 2.5% Sunscreen - Uses - helps prevent sunburn - Keep out of reach of ...
Active ingredients purpose

Avobenzone 3.0% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen

Octocrylene 2.5% Sunscreen
Uses
- helps prevent sunburn
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

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.

Directions

• apply daily after cleansing and toning

• smooth over face & throat

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: Ask a doctor

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

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-sleeve shirts, pants, hats, and sunglasses

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Glycerin, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyglyceryl-3 Methylglucose Distearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Steareth-21, Behenyl Alcohol, Butylene Glycol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Caprooyl Tetrapeptide-3, Salicornia Herbacea Extract, Sodium PCA, Tocopheryl Acetate, Resveratrol, Acetyl Decapeptide-3, Trehalose, Urea, Larix Sibirica Wood Extract, Palmitoyl Tripeptide-8, Carnosine, Potato Starch Modified, Disodium EDTA, Myrothamnus Flabellifolia Leaf/Stem Extract, Kefiran, Sodium Hydroxide, Glyceryl Stearate, Chlorella Vulgaris Extract, Silica, Panthenol, Polyquaternium-51, Glycine Soja (Soybean) Oil, PEG-100 Stearate, Hydrogenated Lecithin, Allantoin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, C13-14 Isoparaffin, Dextran, Caprylic/Capric Triglyceride, Polysorbate 80, Sodium Oleate, Laureth-7, Cetyl Dimethicone, Caprylyl Glycol, Polyquaternium-67, Steareth-2, Polyacrylamide, Carbomer, Synthetic Wax, Alcohol, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbic Acid, Chlorphenesin, Methylparaben, Benzoic Acid, Yellow 5 (CI 19140), Red 4 (CI 14700)
Close
PRINCIPAL DISPLAY PANEL
Anti-Aging Day Cream Sunscreen - Broad Spectrum - Creme De Jour Anti-Age Creme Solaire - Large Spectre - SPF 30 - La Prairie Switerland - 50 ml/ Net Wt. 1.7 Oz.

Anti-Aging Day Cream Sunscreen

Broad Spectrum

Creme De Jour Anti-Age Creme Solaire

Large Spectre

SPF 30

La Prairie Switerland

50 ml/ Net Wt. 1.7 Oz.
Close

INGREDIENTS AND APPEARANCE

Product Information

ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG avobenzone, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68807-302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
STEARETH-21 (UNII: 53J3F32P58)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ASIAN GINSENG (UNII: CUQ3A77YXI)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RESVERATROL (UNII: Q369O8926L)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
LARIX SIBIRICA WOOD (UNII: KSC3PGF73L)
CARNOSINE (UNII: 8HO6PVN24W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PANTHENOL (UNII: WV9CM0O67Z)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SOYBEAN OIL (UNII: 241ATL177A)
PEG-100 STEARATE (UNII: YD01N1999R)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ALLANTOIN (UNII: 344S277G0Z)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM OLEATE (UNII: 399SL044HN)
LAURETH-7 (UNII: Z95S6G8201)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARETH-2 (UNII: V56DFE46J5)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
CARBOMER 934 (UNII: Z135WT9208)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
ALCOHOL (UNII: 3K9958V90M)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)
EUGENOL (UNII: 3T8H1794QW)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68807-302-02	1 in 1 CARTON	01/16/2013
1	NDC:68807-302-01	50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC:68807-302-04	1 in 1 CARTON	01/16/2013
2	NDC:68807-302-03	7 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC:68807-302-06	1 in 1 CARTON	01/16/2013
3	NDC:68807-302-05	3 mL in 1 JAR; Type 0: Not a Combination Product
4	NDC:68807-302-08	1 in 1 CARTON	01/16/2013
4	NDC:68807-302-07	3 mL in 1 JAR; Type 0: Not a Combination Product
5	NDC:68807-302-10	1 in 1 CARTON	01/16/2013
5	NDC:68807-302-09	5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/16/2013

Labeler - Temmentec AG (480586411)

Registrant - Temmentec AG (480586411)

Name	Address	ID/FEI	Business Operations
Establishment
Temmentec AG		480586411	manufacture(68807-302)

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Published Date (What is this?)	Version	Files
Jan 3, 2017	3 (current)	download
Feb 16, 2016	2	download
Jan 19, 2016	1	download

Label: ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

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	NDC
1	68807-302-01
2	68807-302-02 (inactivated)
3	68807-302-03
4	68807-302-04 (inactivated)
5	68807-302-05
6	68807-302-06 (inactivated)
7	68807-302-07
8	68807-302-08 (inactivated)
9	68807-302-09
10	68807-302-10 (inactivated)

Label: ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

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Drug Label Information

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ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

Number of versions: 3

ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

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ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.