ALL YOU NEED PLUS BROAD SPECTRUM SPF 15 24-HOUR MOISTURE/ NORMAL SKIN- avobenzone, homosalate, and octinoxate lotion

ALL YOU NEED PLUS BROAD SPECTRUM SPF 15 24-HOUR MOISTURE/ NORMAL SKIN by

Drug Labeling and Warnings

ALL YOU NEED PLUS BROAD SPECTRUM SPF 15 24-HOUR MOISTURE/ NORMAL SKIN by is a Otc medication manufactured, distributed, or labeled by PRESCRIPTIVES INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.00%
Homosalate 5.00%
Octinoxate 5.00%

Purpose

Sunscreen

Use

helps prevent sunburn

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two 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-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau ◾ dimethicone ◾ butylene glycol ◾ jojoba esters ◾ vinyl dimethicone/methicone silsesquioxane crosspolymer ◾ peg-12 glyceryl dimyristate ◾ yeast extract\faex\extrait de levure ◾ peg-100 stearate ◾ hypnea musciformis (algae) extract ◾ gellidiela acerosa (algae) extract ◾ salvia sclarea (clary) extract ◾ lycium chinense (wolfberry) fruit extract ◾ hordeum vulgare (barley) extract\extrait d'orge ◾ vitis vinifera (grape) fruit extract ◾ cucumis sativus (cucumber) fruit extract ◾ scutellaria baicalensis root extract ◾ morus bombycis (mulberry) root extract ◾ astrocaryum murumuru seed butter ◾ helianthus annuus (sunflower) seedcake ◾ fish (pisces) collagen ◾ sucrose ◾ caffeine ◾ polyethylene ◾ linolenic acid ◾ glycerin ◾ linoleic acid ◾ sodium hyaluronate ◾ polysorbate 40 ◾ pentaerythrityl tetraisostearate ◾ glyceryl stearate ◾ polysilicone-11 ◾ propylene glycol dicaprate ◾ isohexadecane ◾ octocrylene ◾ acetyl glucosamine ◾ cetyl alcohol ◾ steareth-21 ◾ tocopheryl acetate ◾ polysorbate 80 ◾ acetyl hexapeptide-8 ◾ caprylyl glycol ◾ 1,2-hexanediol ◾ acrylamide/sodium acryloyldimethyltaurate copolymer ◾ hydrogenated lecithin ◾ maltodextrin ◾ trehalose ◾ sodium chondroitin sulfate ◾ silica dimethyl silylate ◾ hexylene glycol ◾ fragrance (parfum) ◾ disodium edta ◾ linalool ◾ citronellol ◾ limonene ◾ sodium dehydroacetate ◾ phenoxyethanol <ILN33904>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

Px
PRESCRIPTIVES

All You Need +

Broad Spectrum SPF 15

24-Hour Moisture / Normal Skin

1.7 FL. OZ./OZ.LIQ./50 ml e

INGREDIENTS AND APPEARANCE

ALL YOU NEED PLUS BROAD SPECTRUM SPF 15 24-HOUR MOISTURE/ NORMAL SKIN 
avobenzone, homosalate, and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59158-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03015 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0503 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0503 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
vinyl dimethicone/methicone silsesquioxane crosspolymer (UNII: 9NH1UDD2RR)
peg-12 glyceryl dimyristate (UNII: VS4W16AQ3X)
peg-100 stearate (UNII: YD01N1999R)
clary sage (UNII: U3HSK5JC0Q)
lycium barbarum fruit (UNII: 930626MWDL)
barley (UNII: 5PWM7YLI7R)
grape (UNII: 6X543N684K)
cucumber (UNII: YY7C30VXJT)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
white mulberry (UNII: MN25R0HH5A)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
helianthus annuus seedcake (UNII: 482WYF7XLC)
sucrose (UNII: C151H8M554)
caffeine (UNII: 3G6A5W338E)
high density polyethylene (UNII: UG00KM4WR7)
linolenic acid (UNII: 0RBV727H71)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 40 (UNII: STI11B5A2X)
pentaerythrityl tetraisostearate (UNII: 9D7IK5483F)
glyceryl monostearate (UNII: 230OU9XXE4)
propylene glycol dicaprate (UNII: U783H9JHWY)
isohexadecane (UNII: 918X1OUF1E)
octocrylene (UNII: 5A68WGF6WM)
n-acetylglucosamine (UNII: V956696549)
cetyl alcohol (UNII: 936JST6JCN)
steareth-21 (UNII: 53J3F32P58)
polysorbate 80 (UNII: 6OZP39ZG8H)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
caprylyl glycol (UNII: 00YIU5438U)
1,2-hexanediol (UNII: TR046Y3K1G)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
maltodextrin (UNII: 7CVR7L4A2D)
trehalose (UNII: B8WCK70T7I)
sodium chondroitin sulfate (porcine; 5500 MW) (UNII: H5BJH23Z9A)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hexylene glycol (UNII: KEH0A3F75J)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
linalool, (+/-)- (UNII: D81QY6I88E)
.beta.-citronellol, (r)- (UNII: P01OUT964K)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59158-001-01	1 in 1 CARTON	08/01/2011
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

Labeler - PRESCRIPTIVES INC (151701588)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59158-001) , REPACK(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59158-001) , REPACK(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59158-001) , REPACK(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59158-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59158-001)