DIY BOOSTER SPF 30 FACIAL SERUM UNSCENTED- octinoxate, octisalate, avobenzone, and zinc oxide lotion

DIY Booster SPF 30 Facial Serum Unscented by

Drug Labeling and Warnings

DIY Booster SPF 30 Facial Serum Unscented by is a Otc medication manufactured, distributed, or labeled by Andalou naturals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Octinoxate 7%	Sunscreen
Octisalate 5%	Sunscreen
Avobenzone 3%	Sunscreen
Zinc Oxide 0.1%	Sunscreen

Uses

• 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 or irritation develops and lasts.

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

Directions

• Daily, alone or under make-up.
• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
• Use 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
• Children under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Cetyl Alcohol, Stearyl Alcohol, Sorbitan Oleate Decylglucoside Crosspolymer, Camelina Sativa Seed Oil1, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Resveratrol, Ubiquinone (CoQ10), Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract12, Aspalathus Linearis (Rooibos) Extract12, Hibiscus Sabdariffa Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Tocopherol

1 Certified Organic

2 Fair Trade Ingredients

Other Information

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

Questions

Call (888) 898-6955 or visit www.Andalou.com

SPL UNCLASSIFIED SECTION

Dist. by Andalou Naturals
Novato, CA 94945 USA

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

NEW LOOK

ANDALOU
NATURALS

NON
GMO

DIY Booster

SPF 30
FACIAL SERUM

Unscented

with Resveratrol Q10
Youthful Vitality

Broad Spectrum Protection

FRUIT
STEM
CELL

SCIENCE®

AGE DEFYING

2 fl oz e 58 mL

INGREDIENTS AND APPEARANCE

DIY BOOSTER SPF 30 FACIAL SERUM UNSCENTED 
octinoxate, octisalate, avobenzone, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-0107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
APPLE (UNII: B423VGH5S9)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ACAI (UNII: 46AM2VJ0AW)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
RESVERATROL (UNII: Q369O8926L)
UBIDECARENONE (UNII: EJ27X76M46)
STARCH, CORN (UNII: O8232NY3SJ)
WHITE TEA (UNII: O0M3396E09)
ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-0107-1	1 in 1 CARTON	03/01/2014
1		58 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 FINAL	part352	03/01/2014

Labeler - Andalou naturals (011472720)